- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04490031
Evaluation of Ketamine as Sedative Agent in Endoscopic Retrograde Cholangiopancreatography (ERCP)
July 24, 2020 updated by: Universiti Kebangsaan Malaysia Medical Centre
Randomized Control Study Evaluating Ketamine as Sedative Agent in Endoscopic Retrograde Cholangiopancreatography (ERCP)
This is a study evaluating the usage of Ketamine as sedative agent in ERCP.
The usage of Ketamine will be compared to the standard sedation in our center, which is Midazolam in combination with Pethidine as analgesia.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
This is a double blinded study whereby both the surgeons and patients are blinded from the sedative agent used.
Patients admitted to UKMMC requiring ERCP will randomized into 2 groups after evaluating the inclusion and exclusion criteria.
Patients will be divided into two arms, Midazolam and Ketamine group respectively.
Before the initiation of the the scope, patient would be given specified dose of sedation accordingly.
All the parameters and outcome would be measured during and after the procedure.
Study Type
Interventional
Enrollment (Anticipated)
140
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Muhammad Hafiz Ismail, MBBS
- Phone Number: 6016 3354384
- Email: muhdhafizismail88@gmail.com
Study Contact Backup
- Name: Ian Chik, MD
- Phone Number: 6012 3243404
- Email: ianchikmd@gmail.com
Study Locations
-
-
Kuala Lumpur
-
Bandar Tun Razak, Kuala Lumpur, Malaysia, 56000
- Recruiting
- University Kebangsaan Malaysia Medical Center
-
Contact:
- Zamri Zuhdi, MD
- Phone Number: 6019 2436634
- Email: zamriz7582@gmail.com
-
Contact:
- Ian Chik, MD
- Phone Number: 0123243404
- Email: ianchikmd@gmail.com
-
Principal Investigator:
- Zamri Zuhdi, MD
-
Principal Investigator:
- Azlanudin Azman, MD
-
Principal Investigator:
- Ian Chik, MD
-
Principal Investigator:
- Norma Mohamad, MD
-
Principal Investigator:
- Muhammad Hafiz Ismail, MBBS
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Malaysian citizens of who is able to give valid consent
- Patient planned for ERCP (either emergency or elective)
Exclusion Criteria:
- Known hypersensitivity towards Ketamine or Midazolam
- Patient refusal to participate or unable to give consent
- Increased intracranial pressure, acute stroke (<3 months), intracranial haemorrhage (<3 months)
- Uncontrolled hypertension (BP>160/100) and tachycardia (Heart rate >120)
- Acute myocardial infarction, acute coronary syndrome (<3 months)
- Tachyarrythmia
- Pregnancy
- IVDU or substance abuse patient
- Patient with history of hallucination
- Child's Pugh Class C
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
NO_INTERVENTION: Midazolam group
Standard sedation for ERCP in UKMMC
|
|
EXPERIMENTAL: Ketamine group
|
patient in Ketamine group will be given Ketamine as sedative agent
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
depth of sedation
Time Frame: 1 hour
|
based on Ramsay Sedation Scale, from a scale of 1-6.
|
1 hour
|
completion rate
Time Frame: 1 hour
|
to evaluate completion rate between Ketamine and Midazolam group
|
1 hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Surgeon satisfaction score
Time Frame: within 4 hours after completion of ERCP
|
subjective scoring of surgeon regarding overall experience of the ERCP from a score of 0-10. 0- poor, 5- moderate, 10- excellent |
within 4 hours after completion of ERCP
|
Patient satisfaction score
Time Frame: within 4 hours after completion of ERCP
|
subjective scoring of patients regarding overall experience of the ERCP from a score of 0-10. 0- poor, 5- moderate, 10- excellent |
within 4 hours after completion of ERCP
|
evaluate the occurrence of hypertension, hypotension, bradycardia, tachycardia, hypoxia, respiratory rate abnormality, nausea, vomiting and emergence symptoms
Time Frame: 24 hours
|
recording the adverse events of each sedation.
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Ian Chik, MD, Universiti Kebangsaan Malaysia Medical Centre
- Principal Investigator: Norma mohamad, MD, Universiti Kebangsaan Malaysia Medical Centre
- Principal Investigator: Zamri Zuhdi, MD, Universiti Kebangsaan Malaysia Medical Centre
- Principal Investigator: Azlanudin Azman, MD, Universiti Kebangsaan Malaysia Medical Centre
- Principal Investigator: Muhammad Hafiz Ismail, MD, Universiti Kebangsaan Malaysia Medical Centre
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
March 1, 2020
Primary Completion (ANTICIPATED)
December 31, 2020
Study Completion (ANTICIPATED)
April 30, 2021
Study Registration Dates
First Submitted
March 24, 2020
First Submitted That Met QC Criteria
July 24, 2020
First Posted (ACTUAL)
July 28, 2020
Study Record Updates
Last Update Posted (ACTUAL)
July 28, 2020
Last Update Submitted That Met QC Criteria
July 24, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Dissociative
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Ketamine
Other Study ID Numbers
- Hukm
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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